The Checkup by Singlecare

OCTOBER 17, 2023

Clindamycin is available in various dosage forms, including capsules, oral solution, vaginal cream and gel, topical lotion and gel, and intravenous (IV) injections administered in a hospital setting. Certain vaccines interact with clindamycin , which can cause a diminished vaccine effect. diff (Clostridioides difficile) , CDC.

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ISPE

MARCH 8, 2023

Identification and Analysis of Contamination Trends Three major recall databases—those of the US FDA, the United Kingdom’s Medicine and Healthcare Products Regulatory Agency (UK MHRA), and Australia’s Therapeutic Goods Administration (TGA)—were searched to assess contamination trends in the past five years.

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ISPE

SEPTEMBER 11, 2023

POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. Nature Communications 12, no. Duplication enables rapid scale-up and scale-out, new facilities can be constructed in less than 12 months, and isolated operation avoids cross-contamination. Biotechnology Progress 36, no.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

The Checkup by Singlecare

MARCH 28, 2024

Food and Drug Administration (FDA) to treat many bacterial infections. Amoxicillin is FDA-approved for treating nose, throat, ear, lung, skin, and urinary tract infections. Because amoxicillin isn’t one of the CDC-recommended treatments for gonorrhea or syphilis, there isn’t a standard dosage that’s prescribed.

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MAY 9, 2023

Jaguar Gene Therapy is building a $125 million facility in RTP to manufacture adeno-associated virus (AAV)-based gene therapies, Beam Therapeutics is constructing an $83 million plant to develop precision medicines, and IQVIA, a CRO, opened an innovation lab in the park in 2021, focusing on bioanalytics, vaccines, biomarkers, and genomics.

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ISPE

AUGUST 30, 2022

Recent US FDA data show that the lack of raw material availability contributes to 27% of drug shortages (see Appendix ). It is considered a moderate change by the FDA (CBE30) and NMPA. This change ranges from a moderate change (CBE-30) by the FDA to a minor change not requiring prior approval by the WHO.

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Documentation FDA Packaging Communication 52